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B7.1/IL-2 Leukaemia Cell Vaccine for Non-Transplant AML RFUSIN2-AML2 (NTX)

Primary Purpose

Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AML Cell Vaccine
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Diagnosis of MDS RAEB-2 or primary (de novo) or secondary AML defined according to the WHO classification either as a new diagnosis or as a relapse.
  • Patients for whom the optimal therapy in CR1 would be to undergo allogeneic bone marrow transplantation, but for whom this procedure is either not recommended (e.g. due to comorbidities) or not available (e.g. lack of a suitable donor).

Key Exclusion Criteria:

  • Patients with MDS RAEB-2 or AML and favourable prognostic profile (good risk cytogenetics: t(15;17)(q22;q12~21), inv16(p13q22)/t(16;16)(p13;q22), t(8;21)(q22;q22) or cytogenetically normal AML with NPM1 mutation and absence of Flt-3 ITD).
  • Patients unsuitable for standard induction chemotherapy.
  • Patients who have previously undergone or will be able to undergo allogeneic transplantation.
  • Patients who have had previous or current treatment with any form of investigational immunotherapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    AML Cell Vaccine

    Arm Description

    Outcomes

    Primary Outcome Measures

    Vaccine-related toxicity based on the NCI criteria V4.0
    Frequency, severity of adverse events to the AML cell vaccine

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2015
    Last Updated
    April 12, 2017
    Sponsor
    King's College London
    Collaborators
    King's College Hospital NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02493829
    Brief Title
    B7.1/IL-2 Leukaemia Cell Vaccine for Non-Transplant AML RFUSIN2-AML2 (NTX)
    Official Title
    A Phase I Study of B7.1 (CD80)/IL-2 Immune Gene Therapy for High Risk MDS RAEB-2 and Acute Myeloid Leukaemia Patients Unsuitable for Allogeneic Haematological Stem Cell Transplant
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2017 (Anticipated)
    Primary Completion Date
    May 2020 (Anticipated)
    Study Completion Date
    May 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    King's College London
    Collaborators
    King's College Hospital NHS Trust

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study will be an open label, single arm, phase I study intended to identify the safety and tolerability of "AML Cell Vaccine" given to eligible MDS RAEB-2 and AML patients who have achieved a best response of complete remission or partial remission following their first or second course of standard induction chemotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AML Cell Vaccine
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    AML Cell Vaccine
    Primary Outcome Measure Information:
    Title
    Vaccine-related toxicity based on the NCI criteria V4.0
    Time Frame
    52 weeks
    Title
    Frequency, severity of adverse events to the AML cell vaccine
    Time Frame
    52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria: Diagnosis of MDS RAEB-2 or primary (de novo) or secondary AML defined according to the WHO classification either as a new diagnosis or as a relapse. Patients for whom the optimal therapy in CR1 would be to undergo allogeneic bone marrow transplantation, but for whom this procedure is either not recommended (e.g. due to comorbidities) or not available (e.g. lack of a suitable donor). Key Exclusion Criteria: Patients with MDS RAEB-2 or AML and favourable prognostic profile (good risk cytogenetics: t(15;17)(q22;q12~21), inv16(p13q22)/t(16;16)(p13;q22), t(8;21)(q22;q22) or cytogenetically normal AML with NPM1 mutation and absence of Flt-3 ITD). Patients unsuitable for standard induction chemotherapy. Patients who have previously undergone or will be able to undergo allogeneic transplantation. Patients who have had previous or current treatment with any form of investigational immunotherapy.

    12. IPD Sharing Statement

    Learn more about this trial

    B7.1/IL-2 Leukaemia Cell Vaccine for Non-Transplant AML RFUSIN2-AML2 (NTX)

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